Pressure support and positive end-expiratory pressure versus T-piece during spontaneous breathing trial in difficult weaning from mechanical ventilation: study protocol for the SBT-ICU study.
Critical care
Difficult weaning
Positive end-expiratory pressure
Spontaneous breathing trial
T-piece
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Dec 2022
12 Dec 2022
Historique:
received:
01
08
2022
accepted:
08
11
2022
entrez:
12
12
2022
pubmed:
13
12
2022
medline:
15
12
2022
Statut:
epublish
Résumé
Spontaneous breathing trials are performed in critically ill intubated patients in order to assess readiness to be weaned from mechanical ventilation. In patients with difficult weaning (i.e. not extubated after their first SBT), performing SBT using pressure support with or without positive end-expiratory pressure or using T-piece is debated. As ventilatory support during SBT is greater on pressure support than on T-piece and as positive end-expiratory pressure can prevent weaning-induced pulmonary oedema, we hypothesized that their combination and large use of post-extubation non-invasive ventilation may shorten the time until successful extubation as compared with T-piece, without increasing the rate of reintubation. SBT-ICU is a monocentric prospective open labelled, randomized controlled superiority trial comparing two mechanical ventilation weaning strategies; i.e. daily spontaneous breathing trials using pressure support with positive end-expiratory pressure or T-piece. The primary outcome will be time until successful extubation (defined by as extubation, without reintubation or death within the seven following days). This paper describes the protocol of the SBT-ICU trial. Enrolment of patients in the study is ongoing. ClinicalTrials.gov NCT03861117. Registered on March 1, 2019, before the beginning of inclusion.
Sections du résumé
BACKGROUND
BACKGROUND
Spontaneous breathing trials are performed in critically ill intubated patients in order to assess readiness to be weaned from mechanical ventilation. In patients with difficult weaning (i.e. not extubated after their first SBT), performing SBT using pressure support with or without positive end-expiratory pressure or using T-piece is debated. As ventilatory support during SBT is greater on pressure support than on T-piece and as positive end-expiratory pressure can prevent weaning-induced pulmonary oedema, we hypothesized that their combination and large use of post-extubation non-invasive ventilation may shorten the time until successful extubation as compared with T-piece, without increasing the rate of reintubation.
METHODS
METHODS
SBT-ICU is a monocentric prospective open labelled, randomized controlled superiority trial comparing two mechanical ventilation weaning strategies; i.e. daily spontaneous breathing trials using pressure support with positive end-expiratory pressure or T-piece. The primary outcome will be time until successful extubation (defined by as extubation, without reintubation or death within the seven following days).
DISCUSSION
CONCLUSIONS
This paper describes the protocol of the SBT-ICU trial. Enrolment of patients in the study is ongoing.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03861117. Registered on March 1, 2019, before the beginning of inclusion.
Identifiants
pubmed: 36503500
doi: 10.1186/s13063-022-06896-4
pii: 10.1186/s13063-022-06896-4
pmc: PMC9742015
doi:
Banques de données
ClinicalTrials.gov
['NCT03861117']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
993Informations de copyright
© 2022. The Author(s).
Références
Crit Care. 2006 Feb;10(1):R5
pubmed: 16356211
Eur Respir J. 2007 May;29(5):1033-56
pubmed: 17470624
Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783
pubmed: 27626706
Am J Respir Crit Care Med. 2004 Mar 15;169(6):673-8
pubmed: 14726421
Trials. 2011 May 19;12:127
pubmed: 21595883
Intensive Care Med. 2010 Jul;36(7):1171-9
pubmed: 20352189
Crit Care Med. 2015 Mar;43(3):613-20
pubmed: 25479115
Crit Care. 2016 Nov 12;20(1):369
pubmed: 27836002
Chest. 2001 Oct;120(4):1262-70
pubmed: 11591570
Chest. 2020 Oct;158(4):1446-1455
pubmed: 32439503
Chest. 2017 Jan;151(1):166-180
pubmed: 27818331
Crit Care Med. 2008 Nov;36(11):2986-92
pubmed: 18824909
Crit Care. 2017 Jun 1;21(1):127
pubmed: 28576127